Ramelteon Availability
Ramelteon is FDA-approved and commercially available in the United States as an 8 mg tablet for the treatment of insomnia characterized by difficulty with sleep onset. 1
Regulatory Status and Formulation
Ramelteon tablets (8 mg) are available as light yellow to beige-colored, round, biconvex bevel-edged, film-coated tablets, debossed with "1344" on one side 1
It is the only FDA-approved sleep medication that is not classified as a controlled substance by the US Drug Enforcement Agency, as it demonstrates no abuse liability 2, 3
The medication should be stored at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F), kept tightly closed and protected from moisture and humidity 1
Clinical Positioning
The American Academy of Sleep Medicine recommends ramelteon as a first-line pharmacological option alongside benzodiazepine receptor agonists for insomnia treatment 4
Ramelteon is particularly indicated for sleep-onset insomnia rather than sleep maintenance problems, as it primarily reduces sleep latency by approximately 9-13 minutes but has minimal effect on total sleep time or wake after sleep onset 5
It is especially suitable for patients with a history of substance use disorders or those who prefer non-DEA-scheduled medications 4, 5
Important Prescribing Information
The standard and only approved dose is 8 mg taken approximately 30 minutes before bedtime 5, 2
The FDA approval contains no limitation on duration of use, unlike many other hypnotics 2
Ramelteon works through a unique mechanism as a selective MT1/MT2 melatonin receptor agonist rather than through GABA receptors, making it a "chronohypnotic" that acts on the body's circadian rhythm regulation 6, 3